CS Imaging Suite 5314307

GUDID 60192155314308

CS Imaging Suite

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software
Primary Device ID60192155314308
NIH Device Record Keyb083dfac-e1b8-45ce-94bf-010b76916baa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS Imaging Suite
Version Model NumberCS Imaging Suite
Catalog Number5314307
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155314308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2018-01-15

On-Brand Devices [CS Imaging Suite]

60192155500671CS IMAGING 8 SUITE
60192155314308CS Imaging Suite
60192155943010CS IMAGING CLIENT SERVER SUITE

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